Alexza Pharmaceuticals Receives Updated Day 180 List of Outstanding Issues for ADASUVE™ (Staccato® Loxapine) MAA

Alexza Pharmaceuticals Receives Updated Day 180 List of Outstanding Issues for ADASUVE™ (Staccato® Loxapine) MAA PR Newswire MOUNTAIN VIEW, California, Nov. 19, 2012 MOUNTAIN VIEW, California, Nov. 19, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a CHMP (Committee for Medicinal Products for Human Use) Day 180 Second List of Outstanding Issues (LoOI) from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve™ (Staccato® loxapine). The CHMP Day 180 Second LoOI for ADASUVE contains no major objections to the ADASUVE application, indicating that the two major objections outlined in the initial CHMP Day 180 LoOI have been resolved. According to the timetable included in the CHMP Day 180 Second LoOI, Alexza expects to receive the CHMP Day 210 Opinion in December 2012, as the next official EMA communication on the ADASUVE MAA. "The Alexza and Grupo Ferrer teams have been working diligently with the EMA, to discuss and resolve the two major objections outlined in the initial Day 180 response," said James V. Cassella, PhD, Alexza Executive Vice President and Chief Scientific Officer. "We appreciate the time and efforts of the EMA and CHMP to meet with us, and look forward to continuing to interact with them as we continue to work on the ADASUVE MAA." About Alexza Pharmaceuticals, Inc.